Identity
- Device Name
- Surgical Headlight EUDAMED
- Model / Reference
- FR-SHL-5 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976536010094 EUDAMED
- Basic UDI-DI
- 697653601A001DV EUDAMED
- EMDN Code
- L80 SURGICAL INSTRUMENTS, REUSABLE - VARIOUS ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Surgical Headlight by Zhejiang FuDe Medphotonic Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697653601A001DV | Class I | Active |
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Manufacturer
- Manufacturer
- Zhejiang FuDe Medphotonic Co., Ltd.
- EUDAMED SRN
- CN-MF-000036121
- Authorised Representative
- Umedwings Netherlands B.V. NL-AR-000000444
Sources (1)
- EUDAMED 3b178ab4-b729-4f1f-bbbc-50d0ed788e21 61 fields · synced Jun 17, 2026